Remove Development Remove FDA Approval Remove Hormones Remove Immune Response
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How will $41 million be used to fight chronic and age-related diseases? 

Drug Discovery World

Secreted proteins are a proven class of biologics with largely underutilised therapeutic potential, despite the impact of FDA-approved biologics based on secreted proteins such as insulin, human growth hormone, and erythropoietin.

Protein 52
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Sandoz’s Jubbonti and Wyost Approved as First Interchangeable Biosimilars to Amgen’s Bone Drugs Prolia and Xgeva

XTalks

Risk factors include aging, hormonal changes, low body weight, low calcium intake and use of certain medications. According to the FDA, Jubbonti is approved for the same indications as Prolia, which include individuals at high risk for fracture including postmenopausal women with osteoporosis and men with osteoporosis.

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What Innovative Treatments For Metastatic Breast Cancer are being developed?

Find Me Cure

If you follow our blog you know that we at FindMeCure take updating our readership on treatments in development very seriously. CDK4/6 inhibitors are used alongside hormone therapy. There are antibody drugs targetting those cells that are already FDA approved and there are antibody drugs still in trials.

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Surrogate Endpoints: How to Choose the Best One for Your Rare Disease Trial

XTalks

While the table lists acceptable surrogate endpoints for trials of more common conditions, such as asthma, type 2 diabetes and various cancer types, the document also provides key information to developers of certain rare disease therapies. Both surrogate endpoints could be used to support traditional approval of a new drug or biologic.

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Monthly News Roundup – December 2020

The Pharma Data

The vaccine teaches the cells to make a piece of the spike protein, which triggers an immune response to help prevent illness if later exposed to the virus. In mid-December, the FDA approved Orgovyx (relugolix), the first oral gonadotropin-releasing hormone (GnRH) receptor antagonist for men with advanced prostate cancer.

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Where are the advances in treatments for triple-negative breast cancer?

Drug Discovery World

Diana Spencer investigates therapies in clinical development for triple-negative breast cancer and asks what future treatments might look like. However, because these cancers are not driven by any of the three molecules that can be blocked by targeted hormone receptor drugs, current treatment options are limited.

Protein 52
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FDA Approves Merck’s KEYTRUDA® (pembrolizumab) in Combination With Padcev® (enfortumab vedotin-ejfv) for First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer

The Pharma Data

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Initiate hormone replacement as indicated. Withhold KEYTRUDA depending on severity.